Cleared Special

K202893 - Transcutaneous Electrical Nerve Stimulator
(FDA 510(k) Clearance)

K202893 · Wuxi Jiajian Medical Instrument Co., Ltd. · Neurology

Jun 2021

Decision

263d

Days

Class 2

Risk

K202893 is an FDA 510(k) clearance for the Transcutaneous Electrical Nerve Stimulator, a Stimulator, Nerve, Transcutaneous, For Pain Relief (Class II — Special Controls, product code GZJ), submitted by Wuxi Jiajian Medical Instrument Co., Ltd. (Wuxi, CN). The FDA issued a Cleared decision on June 18, 2021, 263 days after receiving the submission on September 28, 2020. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5890.

Submission Details

510(k) Number	K202893 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 28, 2020
Decision Date	June 18, 2021
Days to Decision	263 days
Submission Type	Special
Review Panel	Neurology (NE)
Summary	Summary PDF